FDA.reportPublic FDA data

NDC 68546-191 - Austedo

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68546-191
Package NDCs from labels
68546-191-07
Manufacturer
Teva Neuroscience, Inc.
Effective date
2025-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Austedo - Teva Neuroscience, Inc.Teva Neuroscience, Inc.2025-02-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68546-191-07AUSTEDO XR7 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE718 mg35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-191AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]35Unmatched20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 90 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.009bef3c-e8ac-46be-b564-a2556adf00812025-10-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEICU Medical Inc.237b39fa-916e-4a54-99c8-4ae9ad54f0562025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
unii: ND2M416302
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
unii: G2M7P15E5P
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Cold and Cough 4 KidsONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALHyland's Inc.e06599ca-fc94-4b2c-829e-f3d4ec866ed62025-10-29WarningsExact identifier
unii: 451W47IQ8X
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
unii: ND2M416302
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC97007188-43fe-416c-a87b-6ccc4d9ae2ec2025-10-29Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.